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H2O VR for Burns 2015 (H2OWC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729259
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
David R. Patterson, National Institute of General Medical Sciences (NIGMS)

Brief Summary:
This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

Condition or disease Intervention/treatment Phase
Pain Burn Behavioral: Virtual Reality Snowworld Behavioral: Virtual Reality slides of nature Behavioral: Control standard nurse wound care Not Applicable

Detailed Description:
This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Water Friendly Virtual Reality for Burns
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Virtual Reality Snowworld
The subjects will receive Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
Behavioral: Virtual Reality Snowworld
The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.

Virtual Reality slides of nature
The subjects will see several slides of the nature through virtual reality goggles during their wound care. The nurse will be doing the wound care.
Behavioral: Virtual Reality slides of nature
The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.

Control standard nurse wound care
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
Behavioral: Control standard nurse wound care
The subjects will receive their standard care during wound care. The nurse will be doing the wound care.




Primary Outcome Measures :
  1. "Pain and anxiety" as measured by Graphic Rating Scale [ Time Frame: up to an hour ]
    Pain and anxiety is being measured



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Compliant and able to complete questionnaires
  • No history of psychiatric disorder
  • Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
  • Able to communicate verbally
  • English-speaking

Exclusion Criteria:

  • Age less than 18 years
  • Not capable of indicating pain intensity
  • Not capable of filling out study measures
  • Evidence of traumatic brain injury
  • History of psychiatric disorder
  • Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
  • Unable to communicate orally
  • Receiving prophylaxis for alcohol or drug withdrawal
  • Developmental disability
  • Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
  • Non-English Speaking
  • Extreme susceptibility to motion sickness
  • Seizure history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729259


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
University of Washington
Investigators
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Principal Investigator: David R. Patterson, Ph.D. University of Washington
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Responsible Party: David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT02729259    
Other Study ID Numbers: 50416EB/002594
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David R. Patterson, National Institute of General Medical Sciences (NIGMS):
VRD
Additional relevant MeSH terms:
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Burns
Wounds and Injuries